Simvastatin in Aneurysmal Subarachnoid Haemorrhage (STASH) a Multicentre Randomised Controlled Clinical Trial "STASH"

Completed

Phase 3 Results N/A

Trial Description

Intracranial bleeding from ruptured blood vessels (called a subarachnoid haemorrhage -SAH) affects 7000 patients each year in the UK and is a source of considerable death and disability, even in young adults. Recent observations indicate that these bleeds can cause reduced cerebral blood flow which leads to a bad outcome. High rates of death and disability occur, and are particularly prevalent when low cerebral blood flow results in stroke. Prevention of cerebral artery spasm and improvement in blood vessel reflexes are the target of modern therapy. Candidate drugs include statins which have an impeccable safety record and multiple potential beneficial actions (improve cerebral blood flow, reduce inflammatory processes, reduce adverse blood coagulation) following SAH.
The investigators plan to use a statin, Simvastatin (40 mg) to improve cerebral blood flow and reduce inflammation. We have already completed a phase 11 study (n=80) which demonstrated potential benefits for acute statin therapy following SAH, and the investigators now wish to conduct a multi-centre phase 111 study to explore any potential clinical benefits in a larger population (n=1600). The purpose is to see whether the positive effects of statins seen in our phase II study translate into clinical benefits - both short term (e.g. reduced need for intensive care) and long term (outcome and wellbeing at 6 months).

Conditions

Interventions

  • Simvastatin Drug
    Intervention Desc: simvastatin 40mg once a day for a maximum of 21 days
    ARM 1: Kind: Experimental
    Label: 11
    Description: simvastatin
  • Placebo Drug
    Intervention Desc: one tablet a day for up to 21 days
    ARM 1: Kind: Experimental
    Label: 1
    Description: placebo

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator)
  • Purpose: Treatment
  • Intervention: Parallel Assignment

Patient Involvement

Patients will be randomized to either placebo or Simvastatin 40 mg. daily and followed for 6 months. At 6 months then will be given mRDS and evaluated for delayed ischemic events.

Outcomes

Type Measure Time Frame Safety Issue
Primary Modified Rankin Disability Score (mRS) at 6 months.
Secondary Need and intensity of delayed ischemic deficit rescue therapy; incidence and duration of delayed ischemic deficits; incidence and severity of sepsis; length of intensive care and total acute hospital stay; discharge destination.
Primary Modified Rankin Disability Score (mRS) at 6 months 6-12 months No
Secondary Need and intensity of delayed ischaemic deficit rescue therapy 1-3 months No
Secondary Incidence and duration of delayed ischaemic deficits 1-3 months No
Secondary Incidence and severity of sepsis 1-3 months No
Secondary Length of intensive care and total acute hospital stay 1-3 months No
Secondary Discharge destination 1-3 months No

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